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Not yet recruitingNCT07890909Updated Oct 22, 2026

A Phase 3b Study of Participant Experience on Povetacicept Administered Via Autoinjector as Compared to Sibeprenlimab Administered Via Prefilled Syringe

A Phase 3 interventional study of Povetacicept and Sibeprenlimab in Immunoglobulin A Nephropathy, sponsored by Vertex Pharmaceuticals Incorporated. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Vertex Pharmaceuticals Incorporated · Phase 3, Interventional, and Treatment

Updated Oct 22, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate participant treatment experience with Povetacicept injection administered via autoinjector relative to Sibeprenlimab injection administered via prefilled syringe (PFS), and to assess the safety and tolerability of Povetacicept in participants with Immunoglobulin A nephropathy (IgAN).

02

Conditions studied

  • Immunoglobulin A Nephropathy
03

In context

Glomerulonephritis, IGA

262 studies on the registry are indexed under Glomerulonephritis, IGA; 102 are open to participants now.

This study's planned enrollment of 40 is below the median of 68 across 212 interventional studies indexed under Glomerulonephritis, IGA.

Browse Glomerulonephritis, IGA studies →

Lead sponsor

Vertex Pharmaceuticals Incorporated is the lead sponsor of 249 studies on the registry; 20 are open to participants now.

Of its 106 completed or terminated interventional studies of FDA-regulated products, 53 (50%) have results posted.

Browse Vertex Pharmaceuticals Incorporated studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Receiving commercial sibeprenlimab 400 mg subcutaneous via PFS for up to (but not exceeding) a maximum of 4 doses of which at least 1 dose is self-injected prior to signing informed consent form
  • Willing and able to comply with scheduled visits, treatment plan including transitioning to povetacicept
  • Biopsy-confirmed primary IgAN
  • 24-hr urine protein/creatinine ratio (UPCR) greater than >0.5 gram (g)/g
  • Estimated glomerular filtration rate (eGFR) greater than or equal to (≥) 30 millilitres per minute (mL/min)/1.73 square meter (m\^2)
  • Able to understand and complete the domains of the Self-Injection Administration Questionnaire (SIAQ)

Key Exclusion Criteria:

  • Use of immunosuppressive or immunomodulatory therapies (except for sibeprenlimab)
  • Rapidly progressive glomerulonephritis with eGFR reduction >50% within 12 weeks of the start of screening

Other protocol defined Inclusion/Exclusion criteria may apply.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Povetacicept

    Participants previously receiving Sibeprenlimab will self-administer Povetacicept.

    Drug: Povetacicept · Drug: Sibeprenlimab

Interventions

  • DrugPovetacicept

    Subcutaneous injection administration.

    Also known as: ALPN-303

  • DrugSibeprenlimab

    Subcutaneous injection administration.

06

What researchers measure

Primary outcomes

  1. Change from Baseline in the Self-Injection Administration Questionnaire (SIAQ) Scores at Week 12 After Transitioning to Povetacicept Injection

    Time frame: Baseline up to Week 12

Secondary outcomes

  1. Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: From Signing of Informed Consent up to Week 24

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Dec 2027, 13 months later.

Of 27 phase 3 interventional studies under Glomerulonephritis, IGA, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 70. This study's planned 13 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 15, 2026
First posted
Oct 22, 2026
StartEst.
Oct 23, 2026
Primary completionEst.
Dec 12, 2027
CompletionEst.
Mar 2, 2028
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07890909
Lead sponsor
Vertex Pharmaceuticals Incorporated
Responsible party
Sponsor
First posted
Oct 22, 2026
Start date
Oct 23, 2026 (estimated)
Primary completion
Dec 12, 2027 (estimated)
Completion
Mar 2, 2028 (estimated)
Last update
Oct 22, 2026

Study contacts

Medical Information
Contact
medicalinfo@vrtx.com
617-341-6777

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Povetacicept · Sibeprenlimab

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